A clinical trial to study the effects of two drugs, Metformin and Sitagliptin as adjunct to insulin therapy on glycemic control in non obese adolescent patients with type 1 diabetes mellitus.

EFFECT OF ORAL HYPOGLYCEMIC DRUGS METFORMIN AND SITAGLIPTIN AS ADJUNCTIVE TO INSULIN THERAPY ON GLYCEMIC CONTROL IN NON-OBESE ADOLESCENTS WITH TYPE I DIABETES - SIIMET

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024386

Enrollment

Registered

2020-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications

Interventions

Intervention1: Insulin Therapy Continued in all three groups Group 1- Metformin 500 mg OD orally for three months: Insulin Therapy Continued in all three groups Group 1- Metformin 500 mg OD orally for

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age:10-16 years 2 Diagnosis of T1D based on revised ISPAD (The 3 International Society for Pediatric and Adolescent Diabetes) criteria 4 At least one pancreatic autoantibody positivity and low C-peptide levels 5 Children on basal-bolus insulin regimen (glargine as long-acting and either lispro or aspart as short acting insulins) HbA1c >=7.5%

Exclusion criteria

Exclusion criteria: •Age above 16 yrs •Uncertain diagnosis of T1D e.g; negative autoantibodies, normal or high C-peptide levels •Patients on insulin therapy other than basal-bolus regimens such as insulin pumps, premixed or split-mix regimens. •Patients diagnosed as T2D or monogenic forms of diabetes •Patients with BMI >=1 SD above the mean for age or >= 85 percentile for age •Patients in partial remission phase (insulin requirement •Patients having good or perfect glycemic control (HbA1c •Refusal or reluctance to participate in the study or inability to adhere to study instructions •Inability to swallow tablets or capsules

Design outcomes

Primary

Measure	Time frame
PRIMARY OBJECTIVES: 1. To determine change in HbA1c levels from baseline to study endpoint 2. To determine change in daily insulin requirements from baseline to the endpoint Timepoint: 6 months -Reruitment 3 months intervention 3 months data analysis	—

Secondary

Measure	Time frame
1.The change in fasting and mean blood glucose levels from study entry to endpoint 2.The change in HOMA-IR from baseline to endpoint 3.The change in C-peptide levels from baseline to endpoint 4.The change in glycemic variability from baseline to endpoint 5.The change in the number of hypoglycemic events from baseline to study endpoint Timepoint: 6 months -Reruitment 3 months intervention 3 months data analysis	—

Measure

Time frame

1.The change in fasting and mean blood glucose levels from study entry to endpoint 2.The change in HOMA-IR from baseline to endpoint 3.The change in C-peptide levels from baseline to endpoint 4.The change in glycemic variability from baseline to endpoint 5.The change in the number of hypoglycemic events from baseline to study endpoint Timepoint: 6 months -Reruitment 3 months intervention 3 months data analysis

—

Countries

India

Contacts

Public ContactDr Devi Dayal

PGIMER Chandigarh

atulgupta7515@gmail.com9418224777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026